The REPOSE trial
The Relative Effectiveness of Pumps over MDI and Structured Education for Type-1 diabetes (REPOSE)
Challenges
People with type 1 diabetes (T1DM) need insulin therapy to sustain life.
The most common treatment is injecting insulin several times a day. Another approach uses insulin pumps, the size of mobile phones, which are attached under the skin through fine tubing and which provide small amounts of insulin.
In the UK, pumps are recommended for people struggling to control their diabetes with injections, and are used far less often than in other countries.
Previous trials of pumps have been small and of short duration, and have failed to control for training in flexible insulin therapy.
The REPOSE trial aimed to assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for a wider population of adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy.
Research
We undertook a pragmatic cluster randomised controlled trial involving 267 people with T1DM in eight secondary care centres across England and Scotland.
Participants were allocated a place on a week-long educational course (DAFNE, Dose Adjustment For Normal Eating) to learn about flexible insulin therapy.
Course groups were then randomly allocated into two groups: one group also received training on how to use a pump to deliver their insulin while the second group used multiple insulin injections, for two years.
The primary outcome was change in HbA1c (a standard surrogate measure of glycaemic control) at two years, in those participants who had a baseline HbA1c of ≥7.5%.
We also collected data at 6, 12 and 24 months on episodes of moderate and severe hypoglycaemia, biochemical outcomes and diabetic ketoacidosis.
Quality of life data were collected using participant self-completed questionnaires and qualitative interviews were undertaken with participants and staff to aid interpretation of the findings. The trial also included a cost-effectiveness analysis.
Results
Our results showed that both groups improved diabetes control after training. Participants using pumps had slightly better control, but differences were small (HbA1c was 0.24% lower than in the injections group).
We found that pumps were not cost-effective, although people using pumps reported better satisfaction with their treatment and in some aspects of their quality of life.
Our study suggests that making insulin pumps more widely available before structured training is unlikely to improve diabetes control or be cost-effective. Providing structured education to more people could be highly beneficial, with pumps made available to those needing better ways of delivering insulin to reach glucose targets.
Impact
The results have been provided to NICE. Our main recommendations were that although these data don’t directly affect NICE pump guidance since participants in REPOSE weren’t those currently those recommended for pump therapy, NICE should consider:
- The guideline on structured education is reinforced. Unfortunately this guidance has been poorly implemented and most patients with type 1 diabetes have not been offered evidence-based structured education.
However NICE guidance currently highlights the importance of DAFNE as a high quality structured education programme in type 1 diabetes and NHS England has recently provided funding for greater provision to patients.
- The new HbA1c target in the updated type 1 guideline, coupled with the need to avoid hypoglycaemia, will probably need increased use of CSII, particularly those highly active in their own management.
There is also a need to review the switching threshold of HbA1c of 8.5% in TA 151.
Trials registration
Study documents
Protocol v11.2 - 23 March 2015 (PDF, 677KB)
Publications
The REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ 2017;356:j1285.
Pollard DJ, Brennan A, Dixon S, Waugh N, Elliott J, Heller S, Lee E, Campbell M, Basarir H & White D (in press). The cost-effectiveness of insulin pumps compared to multiple daily injections, both provided with structured education, for adults with type 1 diabetes: a health economic analysis of the relative effectiveness of pumps over structured education (REPOSE) randomised controlled trial. BMJ Open. View this article in WRRO
White D, Waugh N, Elliott J, Lawton J, Barnard K, Campbell MJ, et al. The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial. BMJ Open 2014;4:e006204. http://dx.doi.org/10.1136/bmjopen-2014-006204
Lawton J, Kirkham J, Rankin D, Barnard K, Cooper CL, Taylor C, et al. Perceptions and experiences of using automated bolus advisors amongst people with type 1 diabetes: a longitudinal qualitative investigation. Diabetes Res Clin Pract 2014;106:443–50. http://dx.doi.org/10.1016/j.diabres.2014.09.011
Lawton J, Kirkham J, White D, Rankin D, Cooper C, Heller S. Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial. Trials 2015;16:3.
Project staff
| Name | Site | Telephone number | |
|---|---|---|---|
| Simon Heller Chief Investigator |
School of Medicine, University of Sheffield |
+44 (0)114 271 3204 | s.heller@sheffield.ac.uk |
| Cindy Cooper Director of CTRU |
ScHARR | +44 (0)114 22 20743 | c.l.cooper@sheffield.ac.uk |
| Diana Papaioannou Research Fellow |
ScHARR | +44 (0)114 22 20766 | d.papaioannou@sheffield.ac.uk |
| David White Trial Manager |
ScHARR | +44 (0)114 22 20807 | d.a.white@sheffield.ac.uk |
| Gemma Hackney Research Assistant |
ScHARR | +44 (0)114 22 24320 | g.hackney@sheffield.ac.uk |
| Lucy Carr Trials Support Officer |
ScHARR | +44 (0)114 22 20866 | lucy.carr@sheffield.ac.uk |
| Tim Chater Data Manager |
ScHARR | +44 (0)114 22 20876 | t.chater@sheffield.ac.uk |
| Kirsty Pemberton Data Officer |
ScHARR | +44 (0) 114 22 20861 | k.j.pemberton@sheffield.ac.uk |
| Mike Campbell Statistician |
ScHARR | +44 (0)114 22 20839 | m.j.campbell@sheffield.ac.uk |
| Munyaradzi Dimairo Statistician |
ScHARR | +44 (0) 114 222 5204 | m.dimairo@sheffield.ac.uk |
| Simon Dixon Professor of Health Economics |
ScHARR | +44 (0)114 22 20724 | s.dixon@sheffield.ac.uk |
| Hasan Basarir Health Economist |
ScHARR | +44 (0)114 22 26397 | h.basarir@sheffield.ac.uk |
| Alan Brennan Professor of Health Economics and Decisions Modelling |
ScHARR | +44 (0)114 22 20684 | a.brennan@sheffield.ac.uk |
| Jen Kruger Health Economist |
ScHARR | +44 (0)114 22 25207 | j.kruger@sheffield.ac.uk |
| Dr Kath Barnard Psychosocial Quantitative Research Fellow |
University of Southampton | + 44 (0) 2380 595548 | K.Barnard@soton.ac.uk |
| Dr Julia Lawton Qualitative Psychosocial Research Fellow |
University of Edinburgh | +44 (0) 1316 506197 | j.lawton@ed.ac.uk |
| Professor Norman Waugh Deputy Chief Investigator |
University of Warwick | norman.waugh@warwick.ac.uk | |
| Gill Thompson National DAFNE director |
Central DAFNE | +44 (0) 1912 934023 | gillian.thompson@northumbria-healthcare.nhs.uk |
Participating centres
| Centre name | Principal Investigator | Educators- DSNs and dieticians |
|---|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | Simon Heller Co-investigator: Jackie Elliott |
Carolin Taylor Carla Gianfrancesco Valerie Gordon Val Nayor Karen Towse |
| Addenbrookes Hospital, Cambridge | Mark Evans Co-investigator: Leila Faghahati |
Candice Ward Sara Hartnell Sarah Donald Katy Davenport Kulbir Kaur Pabla Jane Baillie Karen Callaby Helen Davies |
| Harrogate District Hospital | Peter Hammond Co-investigator: Sutapa Ray |
Janet Carling Joyce Lodge Laura Dinning |
| King’s College Hospital, London | Stephanie Amiel Co-investigator: Pratik Choudhary |
Anita Beckwith Helen Rogers Chris Cheyette Vicky Deprez Alison Cox Philippa Marks |
| Dumfries and Galloway Royal Infirmary |
Fiona Green |
Pam Young Sheena McDonald Katy Valentine |
| Glasgow Royal Infirmary | Robert Lindsay Co-investigator: Brian Kennon |
Janice Shepherd Ann Boal Bernadette Quinn Emma Gibb |
| Royal Infirmary of Edinburgh | Alan Jaap Co-investigator: Alan Patrick |
Alyson Hutchison |
| Nottingham University Hospitals NHS Trust | Peter Mansell Co-investigator: Tasso Gazis |
Nicola Maude |